Founded in 2013, DxNow is a privately-held Delaware C corporation whose corporate headquarters and primary research and development labs are located in Montgomery County, Maryland. This location offers close proximity to Washington, DC, the USFDA, USPTO, NIH, CMS and other agencies relevant to DxNow’s business interests, as well three major airports.

Intellectual Property

DxNow’s products are based on exclusively licensed worldwide patent rights to platform technologies developed by Dr. Demirci and his team at the Demirci Bio-Acoustic MEMS in Medicine Labs (BAMM) at Brigham & Women’s Hospital and Stanford Medicine. The patents pertain to:

Invention for the analysis and sorting of motile cells, as described and claimed in PCT/US2012/038680 and an invention for the sorting of large volumes of sperm cells as described and claimed in U.S. Patent Application US61/906,740 and International Application WO2015077333 (A1).

Inventions pertaining to shadow imaging for detection and characterization of cells (US 61/704,692, PCT/US13/61292, and US 62/121,603)

Additionally, DxNow filed PCT/US 2015/053370 in September 2015 for applications in forensics under license from and jointly-owned with Stanford and the Brigham & Women’s Hospital.

The Demirci BAMM Labs

The Demirci Bio-Acoustic MEMS in Medicine Labs (BAMM) specialize in applying micro- and nanoscale technologies to problems in medicine at the interface between micro/nanoscale engineering and medicine—applying innovative technologies to clinical problems. In this interdisciplinary space at the convergence of engineering, biology and materials science, the goal of the BAMM Labs is to create novel technologies for disposable point-of-care (POC) diagnostics and monitoring of diseases. Applications are unified around expertise in cell manipulation in nanoliter volumes by establishing microfluidic platforms to provide solutions to real world problems in the clinic.

Applications

Assisted Reproductive Technologies (Human & Animal)

More than 70 million couples worldwide cannot conceive naturally and must use assisted reproductive technologies (ART) such as intracytoplasmic sperm injection (ICSI), intrauterine insemination (IUI), or in vitro fertilization (IVF).1,2
In nearly 50% of cases, the problem is attributable to male factors.3 The frequency of male infertility is on the rise and is driving an increasing need for solutions to improve the outcome of ART procedures.

DxNow has designed and developed fertility products to deliver the best outcome for ICSI, IUI and IVF through the use of sperm separation and preparation to aid in selection of the healthiest motile sperm possible.

Evidence Screening & Differential Extraction For DNA Analysis

More than 200,000 rapes and sexual assaults are reported each year in the United States. Worldwide, in excess of 840,000 cases involve sexual assault4. Every 107 seconds, another American is sexually assaulted. South Africa records the highest rates of rape in the world. According to children’s welfare groups, a woman is raped every 17 seconds in South Africa.

DxNow, in collaboration with The Demirci Bio-Acoustic MEMS in Medicine Labs (BAMM) at Stanford Medicine, has developed microfluidic-based platforms for the capture and sorting of a diverse type of cells and pathogens by utilizing highly specific recognition elements including antibodies and carbohydrates. These platform technologies have the potential of being deployed for the detection, capture and quantitation of multiple cell types from unprocessed samples. We have now applied these state-of-the-art technologies to selectively capture sperm from complex bodily fluids, a step which is crucial in forensic DNA analysis of sexual assault samples. Processing of sexual assault evidence generally requires separation of the victim’s cells (epithelial) from the perpetrator’s cells (sperm) and involves time consuming steps of selective cell lysis, centrifugation and separation into female and male DNA fractions (a process known as differential extraction). DxNow technology will provide a catalyst in helping to reduce DNA forensic backgrounds in cases involving sexual assault evidence. Methods for rapid and efficient processing of sexual assault evidence will accelerate forensic investigation and reduce casework backlogs.

DxNow leverages its expertise and proprietary technology in biology, microfluidics, imaging, surface chemistry and product design to supply tools for the research community. For example, both the FERTILE™ and FERTILE PLUS™ microfluidic devices may have applications in sperm toxicity for pharmacological R&D, sperm inhibition related to contraception, and genetic and epigenetic influences on sperm function. DxNow’s innovative proprietary lensless holographic shadow imaging in combination with modified surface chemistry has broad application in cell-based and particle-based capture assay detection.

Building on our expertise in cell sorting tools incorporating shadow imaging for detection and characterization of cells, we are developing medical diagnostic devices leveraging these technologies, along with microfluidic integrated biosensors, to capture and quantify cells from unprocessed whole blood or other body fluids. This healthcare platform technology addresses significant underserved clinical needs in the home and primary care settings for innovative, inexpensive, accurate and easy-to-use point-of-care diagnostics products.

Our technology platform is revolutionary. The inexpensive POC monitoring tools that we can deliver to the home or primary setting have not been available to date.

Our products will decrease healthcare costs and have significant clinical and socio-economic benefits.

This platform will deliver accurate, rapid and inexpensive test results, minimizing unnecessary and costly ER visits and hospitalizations. Specifically, our solutions consist of (i) a disposable single use microfluidic cartridge to capture WBCs and neutrophils and (ii) a portable, easy-to-use lens-free shadow imaging system to rapidly quantify captured cell counts. The easy-to-collect measurements and regular monitoring capabilities will provide much needed, timely treatment of patients before their conditions become acute.

Our lead product focuses on significant underserved medical needs in end-stage renal disease; specifically, addressing critical clinical barriers to more widespread use of peritoneal dialysis. Peritoneal dialysis is a preferred treatment modality that can be performed in the home setting, but is often not utilized due to the risk of peritonitis. By leveraging our technologies, we are delivering an inexpensive, disposable diagnostic that can be used in the home setting by patients to easily capture and analyze neutrophils from their dialysate to detect early indicators of peritoneal infection. Early detection of infections at their onset will enable clinicians to start early treatment, providing significant clinical benefits:

Detecting infection at the onset and preventing the infection from developing to the chronic phase

Monitoring and managing peritoneal dialysis therapy more easily within the home care environment

Minimizing repeat infections, which can lead to peritoneal membrane degradation and forcing patients to switch to the more expensive and less convenient hemodialysis treatment.

Beyond monitoring for peritoneal infection, this proposed platform has broad potential application in monitoring patients receiving chemotherapy and transplants, where the need for a rapid and complete blood count is applicable, as well as detecting catheter infections rapidly in many other clinical procedures.

Our Products

ZyMōt™ Fertility – The Future of Fertility Has Arrived

According to data published by the World Health Organization (WHO), as many as one in five healthy males aged 18 to 25 years old have abnormal sperm counts and only 5 to 15% of sperm are considered normal.

To address the problem, we are commercializing two products in the USA market: ZyMōt™ ICSI and ZyMōt™ Multi Sperm Separation Devices.

Utilizing currently available methods, the embryologist is challenged to select the “right” sperm for use in ART procedures. Furthermore, current procedures requiring centrifugation cause irreversible damage to the sperm due to DNA fragmentation and the generation of reactive oxygen species (ROS). DxNow has developed novel devices for use in assisted reproductive technology (ART) procedures conducted by fertility clinics and OB/GYN practices. The ZyMōt devices are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), intrauterine insemination (IUI), and in vitro fertilization (IVF) procedures. These devices will be the first of their kind in the U.S. market.

The ZyMōt devices simulate the cervical and uterine pathway that sperm must navigate to naturally fertilize an egg, recreating a process that has been preserved in nature for millions of years. With the goal of mimicking nature, ZyMōt devices facilitate the separation and preparation of highly-motile sperm with normal morphology for use in ART procedures. Presenting a simple and straight-forward methodology, the ZyMōt devices provide considerable time savings when compared to conventional methods.

In parallel to our activities in the human market, we are working with key opinion leaders (KOLs) in the veterinary market to validate the utility and function of these products for ART applications in animals.

ZyMōt Device Descriptions:

ZyMōt ICSI and ZyMōt Multi Sperm Separation Devices are used to prepare motile sperm for assisted reproductive technology (ART) procedures. Both devices separate sperm based on motility. The ZyMōt ICSI and the ZyMōt Multi are sterile and single use only. The mechanism of action for both is separation of sperm based on motility within a microenvironment created by the micro-channels of the ZyMōt ICSI or the micro-pores in the filter of the ZyMōt Multi. The primary difference between the devices is the processing volume. The ZyMōt ICSI has a processing volume of 2µl per micro-channel. The ZyMōt Multi is manufactured in two (2) processing volumes, 850µl and 3ml.

The ZyMōt ICSI has 5 micro-channels; each accommodating 2µl of semen. More than one micro-channel is available to accommodate multiple separations. Each channel has an inlet port for applying the semen sample and an outlet port for collecting the motile sperm. The ports are connected by a fluid-filled micro-channel in which the separating occurs. Untreated semen is added through the inlet port. After a period of time, the separated sperm are collected from the outlet port.

The ZyMōt Multi (provided with 850µl and 3ml collection chambers) has an inlet port that communicates with the lower sample chamber. The sample chamber is separated from the upper collection chamber by a microporous filter. Untreated semen is added through the inlet port. After a period of time, the separated sperm are collected from the upper chamber through the outlet port.

Indications for Use:

The ZyMōt ICSI Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI) procedures.

The ZyMōt Multi (850µl) Sperm Separation Device is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

FERTILE™ and FERTILE PLUS™

According to data published by the World Health Organization (WHO), as many as one in five healthy males aged 18 to 25 years old have abnormal sperm counts and only 5 to 15% of sperm are considered normal.

To address the problem, we have developed and are commercializing two products – FERTILE™ for ICSI and FERTILE PLUS™ for ICSI, IUI and IVF (aka ZyMōt™ ICSI and ZyMōt™ Multi in the USA).

Utilizing currently available methods, the embryologist is challenged to select the “right” sperm for use in ART procedures. Furthermore, current procedures requiring centrifugation cause irreversible damage to the sperm due to DNA fragmentation and the generation of reactive oxygen species (ROS).

The result is a simple and fast method, enabling the embryologist to consistently select sperm with higher motility, better morphology, less damaging ROS generation and lower DNA fragmentation.

In parallel to our activities in the human market, we are working with key opinion leaders (KOLs) in the veterinary market to validate the utility and function of these products for ART applications in animals.

FERTILE and FERTILE PLUS are CE registered and currently in use in clinics within Europe and Latin America.

The DxNow CSI-Q™ cartridge is designed to aid the forensic DNA analyst to rapidly identify the most probative sample(s) in forensic DNA casework to submit for further DNA Analysis. CSI-Q is based on the same scientific principles of the innovative NGDE™ technology. Sexual assault evidence samples will be extracted by standard laboratory procedure and an aliquot will be loaded on the chip and washed. If sperm are present in the extract, they will be captured by the oligonucleotide present in the channel and all other cell types will be washed from the chip.

Upon inspection of the chip under a microscope, those samples in which sperm are detected will then be submitted to the testing laboratory for subsequent analysis. The CSI-Q disposable cartridges represent a confirmatory test for the presence of sperm, helping the laboratory to process the most relevant samples, increasing the efficiency and effectiveness of the forensic DNA process.

NGDE™ (Next-Generation Differential Extraction) System

Processing of sexual assault evidence generally requires separation of the victim’s cells (epithelial) from the perpetrator’s cells (sperm) and involves time-consuming steps of selective cell lysis, centrifugation and separation into female and male DNA fractions. To address the challenge of automating and scaling-up this process, DxNow has developed a novel microfluidic system for isolation and quantitation of sperms from forensic evidence.

One exciting aspect of this work is the novel approach we use for sperm capture. Recent investigations have demonstrated that a unique oligosaccharide located on the extracellular matrix of the oocyte represents a ligand for human sperm-egg binding. At DxNow, we will commercialize a disposable microfluidic-based cartridge that can capture sperm cells using this oligosaccharide sequence. Microfluidic-based technologies hold a crucial potential by integrating multiple steps on a single device, improving the scaling capacity, integrating many detection platforms, minimizing reagent consumption and reducing the need for skilled personnel.

With the NGDE system, the forensic differential extraction process will be reduced to under 1 hour and will only require approximately 15 minutes of technician time. Adoption of CSI-Q will enable significant reductions in casework backlogs and more timely processing of new cases.

Quality Statement

DxNow is committed to providing products that fully meet the requirements and expectations of our customers, in compliance with applicable national and international regulations and requirements, as described in our quality manual and quality management procedures.

Our policy objective is to continuously improve upon quality via regular evaluation of established quality objectives with respect to the adequacy of our resources, training, knowledge and skills and customer satisfaction.

Investors

DISCLAIMER

Not an Offer to Purchase or Sell Securities. This overview is for informational purposes and is not an offer to sell or a solicitation of an offer to buy any securities in DxNow, Inc. the “Company” and/or any affiliates. Any offering or solicitation will be made only to qualified prospective investors pursuant to a confidential offering memorandum, and the subscription documents, all of which should be read in their entirety. This business plan contains proprietary information of DxNow, Inc. Neither this business plan nor any of the information contained herein may be reproduced or disclosed to any person without the written consent of DxNow, Inc.